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General News Stories · NOVEMBER 2017

News from the Lupus Foundation of America, Inc.

Major Lupus Stem Cell Study Receives Funding

LFA, Inc. - November 16, 2017

The Lupus Foundation of America announced today it will provide $3.8 million in funding over the next five years to support the first-of-its-kind clinical trial in the United States to evaluate adult mesenchymal stem cells (MSC) as a treatment for lupus. This innovative study is led by Gary Gilkeson, M.D., and Diane Kamen, M.D., of the Medical University of South Carolina (MUSC) and marks a bold step forward in lupus research, which has only had one drug that was specifically developed for lupus and approved by the U.S. Food and Drug Administration (FDA).
The study will determine if MSC stem cell therapy may diminish the often debilitating long-term effects of lupus, reduce the need for medications like steroids, which have harmful side effects, and stop damage to vital organs. Results from initial studies in China show a significant majority of patients whose disease did not respond to current therapies benefited from this type of stem cell therapy, and few patients experienced adverse reactions. In order to continue, this therapy must now be tested through randomized placebo controlled clinical trials to show that it is both safe for people with lupus and more effective than the standard for treatment alone. For this study, one-third of the participants will receive a placebo infusion and the other two-thirds will receive MSC stem cells taken from the umbilical cord of an unrelated donor.
The phase II trial is now moving forward and expected to open enrollment in early 2018 and will recruit a total of 81 individuals with lupus to participate in the study. The trial will also expand to six additional academic centers in Atlanta, Chapel Hill, Chicago, Los Angeles, Rochester, New York City and San Diego.
For more information on the study:https://www.lupus.org/action/stem-cell-therapy-for-lupus

Today, the U.S. Food and Drug Administration has approved a new subcutaneous formulation of Benlysta (belimumab) for subcutaneous use (SC), providing a new, less invasive method for administering this therapy to treat lupus. This new formulation of Benlysta, produced by GSK, would be the first self-injection lupus treatment that people with lupus can administer at home once per week. Previously patients receiving Benlysta had to travel to a medical facility for monthly infusions.

Dr. Susan Manzi, Chair of the Department of Medicine of Allegheny Health Network in Pittsburgh, and also Medical Director for the Lupus Foundation of America said, “The new injection formulation of Benlysta will provide a convenient option for our patients who prefer to administer the medication at home instead of taking the time for a one hour infusion at a remote location. We are always looking for better ways to serve our patients and this is a major step forward.”

Benlysta was first approved as a monthly infusion therapy for lupus in March 2011. Patients on this original formulation had to travel to an infusion center to receive the therapy. GSK’s Benlysta SC will be self-administered as a weekly injection into the fatty layer of tissue just under the skin. It will be available as either a single-dose pre-filled syringe or from a single-dose auto-injector.

Lupus Awareness Month got off to an exciting start yesterday as Congressional leaders released a spending bill that includes $13 million in new funding specifically to advance lupus research, education and awareness! The funding is part of a larger omnibus spending bill that funds the government for the remainder of this fiscal year, which ends September 30. This is great news and is an extremely important step forward in the fight against lupus. The bill includes: • $5 million to establish the first line item for a Lupus Research Program at the Department of Defense (DOD). This is a significant accomplishment! The new program will help us coordinate and strategically direct funding to the most promising lupus research projects. It also means that lupus researchers will not have to compete for scarce dollars against researchers from other disease areas. The program is dedicated entirely to lupus! For more than a decade, the Lupus Foundation of America (Foundation) has led the fight for a dedicated lupus research program at DOD, including testifying before Congress and authoring a white paper describing the connection between lupus and military service.

• $6 million to continue funding for the National Lupus Patient Registry and Patient and Provider Education Programs at the Centers for Disease Control and Prevention (CDC). The bill supports research

examining the costs associated with lupus and its impact on quality of life, as well as continuation of programs to raise awareness, increase knowledge, and enhance the skills of those with lupus and their

health care providers. Congress now has provided nearly $50 million in funding for the registry program!
• $2 million to continue funding for the National Health Education Lupus Program at the Office of Minority Health. This funding will help advance clinical trials and the development of new treatments by

supporting the implementation of a clinical trial education action plan that will help speed enrollment in clinical trials. Total funding for the program is now over $12 million!

The omnibus bill also provides over $34 billion for the National Institutes of Health (NIH), a $2 billion increase over last year! The NIH and the pharmaceutical/biotech industry are the largest sources of lupus funding and we will continue to work with the NIH to direct vital grant funding to lupus research. None of this would have happened without the grassroots outreach by lupus activists throughout the year! YOU made it happen. We are also deeply grateful to the Congressional Lupus Caucus Co-Chairs – Rep. Thomas J. Rooney (R-FL), Rep. William Keating (D-MA), Rep. Ileana Ros-Lehtinen (R-FL), Rep. Eddie Bernice Johnson (D-TX) – and the leaders of the House and Senate Appropriations Committees who championed funding for these vital programs.

Next Steps

Please follow us on Twitter and Facebook, and sign up to become a lupus activist to stay up-to-date on the latest news from Washington and to learn when your outreach to Congress can make the most impact in the fight against lupus. Keep the Momentum Going! Join Us In Washington, D.C. The Foundation’s National Policy Summit has been critical in the fight against lupus. Join us in Washington, D.C. June 26-27 and help us realize even greater accomplishments! Registration is now open. Help us educate Members of Congress about the true nature of the disease and why more must be done to advance our cause on Capitol Hill. Visit http://www.lupus.org/summit to register and learn more.